A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
Stage III Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7
About this trial
This is an interventional treatment trial for Stage III Cutaneous Melanoma AJCC v7
Eligibility Criteria
Inclusion Criteria:
- All patients must be >= 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1
- Patients must have known BRAF mutational status of tumor; wild-type (WT) or mutated, prior to randomization
- Patients must have unresectable stage III or stage IV melanoma according to American Joint Committee on Cancer (AJCC) version (v)7; patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive
- Patients must have measurable disease per RECIST 1.1 criteria; all sites of disease must be evaluated within 4 weeks prior to randomization
- Patients may have had prior systemic therapy in the adjuvant setting (e.g. interferon, BRAF, or MEK agents). Patients may have had prior anti-CTLA-4 in the adjuvant setting, if at least one year from last dose of treatment has passed prior to beginning treatment. Patients may have had any prior programmed cell death (PD)-1/PD-ligand (PD-L)1 agent in the adjuvant setting, if at least one year from last dose of treatment has passed prior to beginning treatment
- Patients must have discontinued chemotherapy, immunotherapy or other investigational agents used in the adjuvant setting >= 4 weeks prior to randomization and recovered from adverse events due to those agents; mitomycin and nitrosoureas must have been discontinued at least 6 weeks prior to entering the study; patients must have discontinued radiation therapy >= 2 weeks prior to entering the study and recovered from any adverse events associated with treatment; prior surgery must be >= 4 weeks from randomization and patients must be fully recovered from post-surgical complications
- White blood count >= 3,000/uL (obtained within 4 weeks prior to randomization)
- Absolute neutrophil count (ANC) >= 1,500/uL (obtained within 4 weeks prior to randomization)
- Platelet count >= 100,000/uL (obtained within 4 weeks prior to randomization)
- Hemoglobin >= 9 g/dL (obtained within 4 weeks prior to randomization)
- Serum creatinine =< 1.5 x upper limit of normal (ULN) or serum creatinine clearance (CrCl) >= 40 ml/min (obtained within 4 weeks prior to randomization)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (=< 5 x ULN for patients with documented liver metastases) (obtained within 4 weeks prior to randomization)
- Alkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement and =< 7 x ULN for patients with known bone involvement) (obtained within 4 weeks prior to randomization)
- Total bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilbert's syndrome (obtained within 4 weeks prior to randomization)
- Serum lactate dehydrogenase (LDH) =< 10 X ULN (obtained within 4 weeks prior to randomization)
- Patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible
Exclusion Criteria:
- Patients must not be pregnant or breast-feeding due to use of cytotoxic immunotherapy and risk of teratogenic side effects; all patients of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a patient of childbearing potential is anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Patients must not conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of study registration and continuing (for patients of child bearing potential) for at least 5 months after the last dose of protocol treatment; patients of childbearing potential must also not donate eggs during this same time period
- Patients may not have had any prior ipilimumab and/or anti-PD-1/PD-L1 agent in the metastatic setting
- Patients must not receive any other investigational agents while on study or within four weeks prior to randomization
- Patient must not have received any live vaccine within 30 days prior to randomization, while participating in the study, and for 4 weeks (28 days) after the last dose of protocol treatment; live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine' patients are permitted to receive inactivated vaccines and any non-live vaccines including those for the seasonal influenza and coronavirus disease 19 (COVID-19) (Note: intranasal influenza vaccines, such as Flu-Mist are live attenuated vaccines and are not allowed); if possible, it is recommended to separate study drug administration from vaccine administration by about a week (primarily, in order to minimize an overlap of adverse events)
- Patients are ineligible if they have any currently active central nervous system (CNS) metastases; patients who have treated brain metastases (with either surgical resection or stereotactic radiosurgery) that have been stable on head magnetic resonance imaging (MRI) or contrast computed tomography (CT) scan for at least 4 weeks following treatment and within 4 weeks prior to randomization are eligible; patients must not have taken any steroids =< 14 days prior to randomization for the purpose of managing their brain metastases; patients with only whole brain irradiation for treatment of CNS metastases will be ineligible
- Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast; patients with other malignancies are eligible if they have been continuously disease-free for > 3 years prior to the time of randomization
- Patients must not have any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), including but not limited to, ongoing or active infection requiring parenteral antibiotics on day 1, history of bleeding diathesis or need for concurrent anticoagulation (international normalized ratio [INR] =< 1.5 and partial thromboplastin time [PTT] within 1.1 x ULN), or psychiatric illness/social situations that would limit compliance with study requirements, interfere with subject's safety, or obtaining informed consent
- Patients with human immunodeficiency virus (HIV) infection are ineligible; due to the mechanism of action of ipilimumab and GM-CSF, activity and side effects in an immune compromised patient are unknown
- Patients with evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are not eligible; patients with cleared HBV and HCV (0 viral load) infection will be allowed
- Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (e.g., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to randomization are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study
- Exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis); other CNS autoimmune disease (e.g., multiple sclerosis)
- Patients must not have a history of inflammatory bowel disease or diverticulitis (history of diverticulosis is allowed)
- Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that in the opinion of the investigator may interfere with compliance, make the administration of the study drugs hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea; patients must not have an active infection requiring current treatment with parenteral antibiotics
Sites / Locations
- University of Alabama at Birmingham Cancer CenterRecruiting
- Kingman Regional Medical CenterRecruiting
- CARTI Cancer CenterRecruiting
- John L McClellan Memorial Veterans Hospital
- Kaiser Permanente-AnaheimRecruiting
- PCR OncologyRecruiting
- Sutter Auburn Faith HospitalRecruiting
- Sutter Cancer Centers Radiation Oncology Services-AuburnRecruiting
- Kaiser Permanente-Baldwin ParkRecruiting
- Kaiser Permanente-BellflowerRecruiting
- Alta Bates Summit Medical Center-Herrick CampusRecruiting
- Mills-Peninsula Medical CenterRecruiting
- Sutter Cancer Centers Radiation Oncology Services-Cameron ParkRecruiting
- Eden Hospital Medical CenterRecruiting
- Sutter Davis HospitalRecruiting
- City of Hope Comprehensive Cancer Center
- Kaiser Permanente DublinRecruiting
- Kaiser Permanente-FontanaRecruiting
- Palo Alto Medical Foundation-FremontRecruiting
- Kaiser Permanente-FresnoRecruiting
- Kaiser Permanente - Harbor CityRecruiting
- Kaiser Permanente-IrvineRecruiting
- Kaiser Permanente Los Angeles Medical CenterRecruiting
- Kaiser Permanente West Los AngelesRecruiting
- Memorial Medical CenterRecruiting
- Kaiser Permanente-ModestoRecruiting
- Palo Alto Medical Foundation-Camino DivisionRecruiting
- Palo Alto Medical Foundation-Gynecologic OncologyRecruiting
- Sutter Cancer Research ConsortiumRecruiting
- Kaiser Permanente-OaklandRecruiting
- Kaiser Permanente-OntarioRecruiting
- Saint Joseph Hospital - OrangeRecruiting
- UC Irvine Health/Chao Family Comprehensive Cancer CenterRecruiting
- Palo Alto Medical Foundation Health CareRecruiting
- Stanford Cancer Institute Palo AltoRecruiting
- Kaiser Permanente - Panorama CityRecruiting
- Kaiser Permanente-RichmondRecruiting
- Kaiser Permanente-RiversideRecruiting
- Kaiser Permanente-RosevilleRecruiting
- Sutter Cancer Centers Radiation Oncology Services-RosevilleRecruiting
- Sutter Roseville Medical CenterRecruiting
- Kaiser Permanente Downtown CommonsRecruiting
- Sutter Medical Center SacramentoRecruiting
- Kaiser Permanente-South SacramentoRecruiting
- Kaiser Permanente - SacramentoRecruiting
- Kaiser Permanente-San Diego MissionRecruiting
- Kaiser Permanente-San Diego ZionRecruiting
- Naval Medical Center -San Diego
- California Pacific Medical Center-Pacific CampusRecruiting
- Kaiser Permanente-Santa Teresa-San JoseRecruiting
- Kaiser Permanente San LeandroRecruiting
- Kaiser Permanente-San MarcosRecruiting
- Mills Health CenterRecruiting
- Kaiser Permanente-San RafaelRecruiting
- Kaiser San Rafael-GallinasRecruiting
- Kaiser Permanente Medical Center - Santa ClaraRecruiting
- Palo Alto Medical Foundation-Santa CruzRecruiting
- Sutter Pacific Medical FoundationRecruiting
- Kaiser Permanente-StocktonRecruiting
- Palo Alto Medical Foundation-SunnyvaleRecruiting
- City of Hope Upland
- Sutter Cancer Centers Radiation Oncology Services-VacavilleRecruiting
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-VallejoRecruiting
- Sutter Solano Medical Center/Cancer CenterRecruiting
- Kaiser Permanente-Walnut CreekRecruiting
- Kaiser Permanente-Woodland HillsRecruiting
- The Medical Center of Aurora
- Boulder Community Hospital
- Penrose-Saint Francis HealthcareRecruiting
- Rocky Mountain Cancer Centers-PenroseRecruiting
- Saint Francis Cancer CenterRecruiting
- Kaiser Permanente-FranklinRecruiting
- Porter Adventist HospitalRecruiting
- Presbyterian - Saint Lukes Medical Center - Health One
- SCL Health Saint Joseph Hospital
- Rose Medical Center
- Mercy Medical Center
- Southwest Oncology PC
- Mountain Blue Cancer Care Center - Swedish
- Rocky Mountain Cancer Centers - Swedish
- Swedish Medical CenterRecruiting
- The Melanoma and Skin Cancer Institute
- North Colorado Medical CenterRecruiting
- Kaiser Permanente-Rock CreekRecruiting
- Saint Anthony Hospital
- Kaiser Permanente-Lone TreeRecruiting
- Sky Ridge Medical Center
- Longmont United Hospital
- McKee Medical CenterRecruiting
- Parker Adventist HospitalRecruiting
- Saint Mary Corwin Medical Center
- SCL Health Lutheran Medical Center
- Smilow Cancer Hospital Care Center - GuilfordRecruiting
- Smilow Cancer Hospital Care Center at Saint FrancisRecruiting
- Smilow Cancer Center/Yale-New Haven HospitalRecruiting
- Yale UniversityRecruiting
- Smilow Cancer Hospital-Waterbury Care CenterRecruiting
- Smilow Cancer Hospital Care Center - WaterfordRecruiting
- MedStar Georgetown University HospitalRecruiting
- MedStar Washington Hospital CenterRecruiting
- UM Sylvester Comprehensive Cancer Center at AventuraRecruiting
- UM Sylvester Comprehensive Cancer Center at Coral GablesRecruiting
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachRecruiting
- Holy Cross HospitalRecruiting
- University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
- UM Sylvester Comprehensive Cancer Center at KendallRecruiting
- UM Sylvester Comprehensive Cancer Center at PlantationRecruiting
- Moffitt Cancer Center-International PlazaRecruiting
- Moffitt Cancer Center - McKinley CampusRecruiting
- Moffitt Cancer CenterRecruiting
- University Cancer and Blood Center LLCRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Northside HospitalRecruiting
- Augusta University Medical CenterRecruiting
- Northside Hospital-Forsyth
- Dekalb Medical Center
- Northside Hospital - DuluthRecruiting
- Northside Hospital - GwinnettRecruiting
- Lewis Cancer and Research Pavilion at Saint Joseph's/CandlerRecruiting
- Summit Cancer Care-Candler
- Hawaii Cancer Care - Westridge
- Pali Momi Medical Center
- Queen's Cancer Center - Pearlridge
- Straub Pearlridge Clinic
- The Cancer Center of Hawaii-Pali Momi
- The Queen's Medical Center - West Oahu
- Hawaii Cancer Care Inc - Waterfront Plaza
- Island Urology
- Queen's Cancer Cenrer - POB I
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Hawaii Diagnostic Radiology Services LLC
- Kuakini Medical Center
- Queen's Cancer Center - Kuakini
- The Cancer Center of Hawaii-Liliha
- Kaiser Permanente Moanalua Medical CenterRecruiting
- Kapiolani Medical Center for Women and Children
- Straub Medical Center - Kahului Clinic
- Castle Medical CenterRecruiting
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Alphonsus Cancer Care Center-CaldwellRecruiting
- Kootenai Health - Coeur d'AleneRecruiting
- Walter Knox Memorial HospitalRecruiting
- Idaho Urologic Institute-MeridianRecruiting
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Kootenai Clinic Cancer Services - Post FallsRecruiting
- Kootenai Cancer ClinicRecruiting
- Rush - Copley Medical CenterRecruiting
- Saint Joseph Medical Center
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Memorial Hospital of CarbondaleRecruiting
- SIH Cancer InstituteRecruiting
- Illinois CancerCare-CarthageRecruiting
- Centralia Oncology ClinicRecruiting
- Northwestern UniversityRecruiting
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Illinois CancerCare-DixonRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Illinois CancerCare-EurekaRecruiting
- NorthShore University HealthSystem-Evanston HospitalRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Western Illinois Cancer Treatment CenterRecruiting
- NorthShore University HealthSystem-Glenbrook HospitalRecruiting
- NorthShore University HealthSystem-Highland Park HospitalRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Cancer Care Center of O'FallonRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Illinois CancerCare-PekinRecruiting
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment CenterRecruiting
- Illinois CancerCare-PeoriaRecruiting
- OSF Saint Francis Radiation Oncology at Peoria Cancer CenterRecruiting
- Methodist Medical Center of IllinoisRecruiting
- OSF Saint Francis Medical CenterRecruiting
- Illinois CancerCare-PeruRecruiting
- Valley Radiation OncologyRecruiting
- Illinois CancerCare-PrincetonRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Southwest Illinois Health Services LLP
- Carle Cancer CenterRecruiting
- The Carle Foundation HospitalRecruiting
- Illinois CancerCare - WashingtonRecruiting
- Rush-Copley Healthcare CenterRecruiting
- Deaconess Clinic DowntownRecruiting
- Indiana University/Melvin and Bren Simon Cancer CenterRecruiting
- Franciscan Health IndianapolisRecruiting
- Franciscan Saint Anthony Health-Michigan City
- Woodland Cancer Care Center
- Franciscan Health MooresvilleRecruiting
- Chancellor Center for OncologyRecruiting
- Reid HealthRecruiting
- Mary Greeley Medical CenterRecruiting
- McFarland Clinic - AmesRecruiting
- McFarland Clinic - BooneRecruiting
- McFarland Clinic - Trinity Cancer CenterRecruiting
- McFarland Clinic - JeffersonRecruiting
- McFarland Clinic - MarshalltownRecruiting
- Siouxland Regional Cancer CenterRecruiting
- Cancer Center of Kansas - ChanuteRecruiting
- Cancer Center of Kansas - Dodge CityRecruiting
- Cancer Center of Kansas - El DoradoRecruiting
- Cancer Center of Kansas - Fort Scott
- HaysMed University of Kansas Health SystemRecruiting
- Cancer Center of Kansas-IndependenceRecruiting
- University of Kansas Cancer CenterRecruiting
- Cancer Center of Kansas-KingmanRecruiting
- Lawrence Memorial HospitalRecruiting
- Cancer Center of Kansas-LiberalRecruiting
- Cancer Center of Kansas-ManhattanRecruiting
- Cancer Center of Kansas - McPhersonRecruiting
- Cancer Center of Kansas - NewtonRecruiting
- Olathe Health Cancer CenterRecruiting
- University of Kansas Cancer Center-Overland ParkRecruiting
- University of Kansas Hospital-Indian Creek CampusRecruiting
- Cancer Center of Kansas - ParsonsRecruiting
- Cancer Center of Kansas - PrattRecruiting
- Cancer Center of Kansas - SalinaRecruiting
- Salina Regional Health CenterRecruiting
- Cotton O'Neil Cancer Center / Stormont Vail HealthRecruiting
- University of Kansas Health System Saint Francis CampusRecruiting
- Cancer Center of Kansas - WellingtonRecruiting
- University of Kansas Hospital-Westwood Cancer CenterRecruiting
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts TowerRecruiting
- Ascension Via Christi Hospitals WichitaRecruiting
- Cancer Center of Kansas - WichitaRecruiting
- Cancer Center of Kansas - WinfieldRecruiting
- Oncology Hematology Care Inc-Crestview
- The James Graham Brown Cancer Center at University of Louisville
- LSU Health Baton Rouge-North ClinicRecruiting
- Our Lady of The LakeRecruiting
- Louisiana Hematology Oncology Associates LLC
- Mary Bird Perkins Cancer Center
- Ochsner Health Center-Summa
- Our Lady of the Lake Physicians Group - Medical OncologyRecruiting
- Medical Center of Baton Rouge
- Ochsner High Grove
- Mary Bird Perkins Cancer Center - Covington
- Northshore Oncology Associates-Covington
- Mary Bird Perkins Cancer Center - Houma
- Oncology Center of The South Incorporated
- Ochsner Medical Center Kenner
- Ochsner LSU Health Monroe Medical Center
- Louisiana State University Health Science Center
- University Medical Center New Orleans
- Ochsner Medical Center Jefferson
- LSU Health Sciences Center at Shreveport
- CHRISTUS Highland Medical Center
- Eastern Maine Medical Center
- Lafayette Family Cancer Center-EMMC
- Maine Center for Cancer Medicine-Kennebunk
- Maine Center for Cancer Medicine-Scarborough
- Greater Baltimore Medical CenterRecruiting
- Sinai Hospital of Baltimore
- Saint Agnes Hospital
- MedStar Franklin Square Medical Center/Weinberg Cancer InstituteRecruiting
- UPMC Western Maryland
- Northwest Hospital Center
- Massachusetts General Hospital Cancer CenterRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- Dana-Farber Cancer InstituteRecruiting
- Baystate Medical CenterRecruiting
- UMass Memorial Medical Center - University Campus
- Hickman Cancer Center
- Saint Joseph Mercy HospitalRecruiting
- Bronson Battle Creek
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- Saint Joseph Mercy CantonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
- Caro Cancer CenterRecruiting
- Saint Joseph Mercy ChelseaRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
- Hematology Oncology Consultants-ClarkstonRecruiting
- Newland Medical Associates-ClarkstonRecruiting
- Beaumont Hospital - Dearborn
- Ascension Saint John HospitalRecruiting
- Great Lakes Cancer Management Specialists-Doctors ParkRecruiting
- Genesee Cancer and Blood Disease Treatment CenterRecruiting
- Genesee Hematology Oncology PCRecruiting
- Genesys Hurley Cancer InstituteRecruiting
- Hurley Medical CenterRecruiting
- Spectrum Health at Butterworth CampusRecruiting
- Trinity Health Grand Rapids HospitalRecruiting
- Academic Hematology Oncology SpecialistsRecruiting
- Great Lakes Cancer Management Specialists-Van Elslander Cancer CenterRecruiting
- Michigan Breast Specialists-Grosse Pointe Woods
- Allegiance Health
- Bronson Methodist HospitalRecruiting
- West Michigan Cancer CenterRecruiting
- Ascension Borgess Cancer CenterRecruiting
- Borgess Medical CenterRecruiting
- Sparrow HospitalRecruiting
- Hope Cancer Clinic
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- Great Lakes Cancer Management Specialists-Macomb Medical CampusRecruiting
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of MarletteRecruiting
- Toledo Clinic Cancer Centers-Monroe
- Trinity Health Muskegon HospitalRecruiting
- Cancer and Hematology Centers of Western Michigan - Norton ShoresRecruiting
- 21st Century Oncology-PontiacRecruiting
- Hope Cancer CenterRecruiting
- Newland Medical Associates-PontiacRecruiting
- Saint Joseph Mercy OaklandRecruiting
- Spectrum Health Reed City Hospital
- Great Lakes Cancer Management Specialists-Rochester Hills
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's HospitalRecruiting
- Oncology Hematology Associates of Saginaw Valley PCRecruiting
- Ascension Providence Hospitals - SouthfieldRecruiting
- Bhadresh Nayak MD PC-Sterling HeightsRecruiting
- Ascension Saint Joseph HospitalRecruiting
- Munson Medical Center
- William Beaumont Hospital - Troy
- Advanced Breast Care Center PLLCRecruiting
- Great Lakes Cancer Management Specialists-Macomb Professional BuildingRecruiting
- Macomb Hematology Oncology PCRecruiting
- Michigan Breast Specialists-WarrenRecruiting
- Saint John Macomb-Oakland HospitalRecruiting
- Saint Mary's Oncology/Hematology Associates of West BranchRecruiting
- University of Michigan Health - West
- Huron Gastroenterology PCRecruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Riverwood Healthcare CenterRecruiting
- Essentia Health - Baxter ClinicRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Essentia Health Saint Joseph's Medical CenterRecruiting
- Fairview Ridges Hospital
- Minnesota Oncology - BurnsvilleRecruiting
- Cambridge Medical CenterRecruiting
- Mercy HospitalRecruiting
- Essentia Health - Deer River ClinicRecruiting
- Essentia Health Saint Mary's - Detroit Lakes ClinicRecruiting
- Essentia Health Cancer CenterRecruiting
- Essentia Health Saint Mary's Medical CenterRecruiting
- Miller-Dwan HospitalRecruiting
- Fairview Southdale HospitalRecruiting
- Essentia Health - Ely ClinicRecruiting
- Lake Region Healthcare Corporation-Cancer Care
- Essentia Health - FosstonRecruiting
- Unity Hospital
- Essentia Health Hibbing ClinicRecruiting
- Essentia Health - International Falls ClinicRecruiting
- Fairview Clinics and Surgery Center Maple GroveRecruiting
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Saint John's Hospital - HealtheastRecruiting
- Abbott-Northwestern HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Health Partners IncRecruiting
- Monticello Cancer CenterRecruiting
- Essentia Health - Moose Lake ClinicRecruiting
- New Ulm Medical CenterRecruiting
- Essentia Health - Park RapidsRecruiting
- Fairview Northland Medical CenterRecruiting
- North Memorial Medical Health CenterRecruiting
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- United HospitalRecruiting
- Essentia Health SandstoneRecruiting
- Saint Francis Regional Medical CenterRecruiting
- Lakeview HospitalRecruiting
- Sanford Thief River Falls Medical CenterRecruiting
- Essentia Health Virginia ClinicRecruiting
- Ridgeview Medical CenterRecruiting
- Rice Memorial HospitalRecruiting
- Minnesota Oncology Hematology PA-WoodburyRecruiting
- Sanford Cancer Center WorthingtonRecruiting
- Fairview Lakes Medical CenterRecruiting
- University of Mississippi Medical CenterRecruiting
- Parkland Health Center-Bonne Terre
- Saint Francis Medical CenterRecruiting
- Southeast Cancer CenterRecruiting
- Saint Luke's HospitalRecruiting
- Parkland Health Center - FarmingtonRecruiting
- Capital Region Southwest CampusRecruiting
- Truman Medical CentersRecruiting
- University of Kansas Cancer Center - NorthRecruiting
- University of Kansas Cancer Center - Lee's SummitRecruiting
- University of Kansas Cancer Center at North Kansas City HospitalRecruiting
- Heartland Regional Medical Center
- Missouri Baptist Medical CenterRecruiting
- Sainte Genevieve County Memorial HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- CoxHealth South HospitalRecruiting
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Community Hospital of AnacondaRecruiting
- Billings Clinic Cancer Center
- Bozeman Deaconess HospitalRecruiting
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Saint Elizabeth Regional Medical CenterRecruiting
- Great Plains Health Callahan Cancer Center
- Nebraska Cancer Specialists/Oncology Hematology West PC - MECCRecruiting
- Nebraska Methodist HospitalRecruiting
- Oncology Associates PCRecruiting
- Alegent Health Immanuel Medical CenterRecruiting
- Alegent Health Bergan Mercy Medical CenterRecruiting
- Alegent Health Lakeside HospitalRecruiting
- Creighton University Medical CenterRecruiting
- Midlands Community HospitalRecruiting
- Carson Tahoe Regional Medical CenterRecruiting
- Cancer and Blood Specialists-HendersonRecruiting
- Comprehensive Cancer Centers of Nevada - HendersonRecruiting
- Comprehensive Cancer Centers of Nevada-Horizon RidgeRecruiting
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven HillsRecruiting
- Comprehensive Cancer Centers of Nevada-Southeast HendersonRecruiting
- GenesisCare USA - HendersonRecruiting
- Las Vegas Urology - Green ValleyRecruiting
- Las Vegas Urology - PebbleRecruiting
- Urology Specialists of Nevada - Green ValleyRecruiting
- Las Vegas Urology - PecosRecruiting
- Desert West Surgery
- OptumCare Cancer Care at CharlestonRecruiting
- University Medical Center of Southern NevadaRecruiting
- Hope Cancer Care of NevadaRecruiting
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada CentralRecruiting
- Urology Specialists of Nevada - CentralRecruiting
- GenesisCare USA - Las VegasRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- Sunrise Hospital and Medical CenterRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Las Vegas Prostate Cancer CenterRecruiting
- Las Vegas Urology - SunsetRecruiting
- Urology Specialists of Nevada - SouthwestRecruiting
- Radiation Oncology Centers of Nevada SoutheastRecruiting
- Ann M Wierman MD LTDRecruiting
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - NorthwestRecruiting
- GenesisCare USA - Vegas TenayaRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Las Vegas Urology - Cathedral RockRecruiting
- Las Vegas Urology - Smoke RanchRecruiting
- OptumCare Cancer Care at MountainViewRecruiting
- Urology Specialists of Nevada - NorthwestRecruiting
- Alliance for Childhood Diseases/Cure 4 the Kids FoundationRecruiting
- Comprehensive Cancer Centers of Nevada - Town CenterRecruiting
- Comprehensive Cancer Centers of Nevada-SummerlinRecruiting
- Summerlin Hospital Medical CenterRecruiting
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of NevadaRecruiting
- GenesisCare USA - Fort ApacheRecruiting
- OptumCare Cancer Care at Fort ApacheRecruiting
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central ValleyRecruiting
- University Cancer CenterRecruiting
- Hope Cancer Care of Nevada-PahrumpRecruiting
- Renown Regional Medical CenterRecruiting
- Saint Mary's Regional Medical CenterRecruiting
- Radiation Oncology AssociatesRecruiting
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- Memorial Sloan Kettering Basking RidgeRecruiting
- Hackensack University Medical CenterRecruiting
- Lovelace Medical Center-Saint Joseph SquareRecruiting
- University of New Mexico Cancer CenterRecruiting
- New Mexico Oncology Hematology Consultants
- Presbyterian Kaseman HospitalRecruiting
- Presbyterian Rust Medical Center/Jorgensen Cancer CenterRecruiting
- Christus Saint Vincent Regional Cancer Center
- Roswell Park Cancer Institute
- Memorial Sloan Kettering CommackRecruiting
- Mary Imogene Bassett HospitalRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- University of RochesterRecruiting
- AdventHealth Infusion Center Asheville
- Southeastern Medical Oncology Center-ClintonRecruiting
- Southeastern Medical Oncology Center-GoldsboroRecruiting
- Wayne Memorial Hospital
- Hendersonville Hematology and Oncology at PardeeRecruiting
- Margaret R Pardee Memorial HospitalRecruiting
- Onslow Memorial Hospital
- Southeastern Medical Oncology Center-JacksonvilleRecruiting
- Vidant Oncology-KenansvilleRecruiting
- Vidant Oncology-KinstonRecruiting
- Vidant Oncology-RichlandsRecruiting
- Sanford Bismarck Medical CenterRecruiting
- Essentia Health Cancer Center-South University ClinicRecruiting
- Sanford South University Medical CenterRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Clinic North-Fargo
- Sanford Roger Maris Cancer CenterRecruiting
- Essentia Health - Jamestown ClinicRecruiting
- UH Seidman Cancer Center at UH Avon Health CenterRecruiting
- UHHS-Chagrin Highlands Medical CenterRecruiting
- Indu and Raj Soin Medical CenterRecruiting
- Strecker Cancer Center-BelpreRecruiting
- Saint Elizabeth Boardman HospitalRecruiting
- Dayton Physicians LLC-Miami Valley SouthRecruiting
- Miami Valley Hospital SouthRecruiting
- Adena Regional Medical CenterRecruiting
- Oncology Hematology Care Inc-Eden Park
- Oncology Hematology Care Inc-Mercy West
- University of Cincinnati Cancer Center-UC Medical CenterRecruiting
- Oncology Hematology Care Inc-Anderson
- Oncology Hematology Care Inc-KenwoodRecruiting
- Oncology Hematology Care Inc-Blue Ash
- Case Western Reserve UniversityRecruiting
- MetroHealth Medical CenterRecruiting
- Mount Carmel East HospitalRecruiting
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Grant Medical Center
- The Mark H Zangmeister CenterRecruiting
- Mount Carmel Health Center WestRecruiting
- Doctors Hospital
- Good Samaritan Hospital - Dayton
- Dayton Blood and Cancer CenterRecruiting
- Miami Valley HospitalRecruiting
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Miami Valley Hospital NorthRecruiting
- Delaware Health Center-Grady Cancer CenterRecruiting
- Grady Memorial HospitalRecruiting
- Columbus Oncology and Hematology Associates
- Dublin Methodist HospitalRecruiting
- Oncology Hematology Care Inc-Healthplex
- Armes Family Cancer CenterRecruiting
- Blanchard Valley HospitalRecruiting
- Orion Cancer CareRecruiting
- Atrium Medical Center-Middletown Regional HospitalRecruiting
- Dayton Physicians LLC-AtriumRecruiting
- Dayton Physicians LLC-WayneRecruiting
- Miami Valley Cancer Care and InfusionRecruiting
- Wayne HospitalRecruiting
- Mount Carmel Grove City HospitalRecruiting
- Zangmeister Center Grove CityRecruiting
- Greater Dayton Cancer CenterRecruiting
- Kettering Medical CenterRecruiting
- Fairfield Medical CenterRecruiting
- Saint Rita's Medical CenterRecruiting
- OhioHealth Mansfield Hospital
- Marietta Memorial HospitalRecruiting
- OhioHealth Marion General Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- UH Seidman Cancer Center at Lake Health Mentor CampusRecruiting
- Dayton Physicians LLC-Signal Point
- Knox Community HospitalRecruiting
- Mount Carmel New Albany Surgical HospitalRecruiting
- Licking Memorial HospitalRecruiting
- Newark Radiation OncologyRecruiting
- Saint Charles Hospital
- Mercy Health Perrysburg Cancer CenterRecruiting
- Southern Ohio Medical CenterRecruiting
- UH Seidman Cancer Center at Firelands Regional Medical CenterRecruiting
- Dayton Physicians LLC-Wilson
- Springfield Regional Cancer CenterRecruiting
- Springfield Regional Medical CenterRecruiting
- ProMedica Flower Hospital
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
- Saint Vincent Mercy Medical CenterRecruiting
- Mercy Health - Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Dayton Physicians LLC - TroyRecruiting
- Upper Valley Medical CenterRecruiting
- Saint Joseph Warren HospitalRecruiting
- University of Cincinnati Cancer Center-West ChesterRecruiting
- Saint Ann's HospitalRecruiting
- UH Seidman Cancer Center at Saint John Medical CenterRecruiting
- Saint Elizabeth Youngstown HospitalRecruiting
- Genesis Healthcare System Cancer Care CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Saint Alphonsus Medical Center-Baker CityRecruiting
- Saint Alphonsus Medical Center-OntarioRecruiting
- Lehigh Valley Hospital-Cedar CrestRecruiting
- UPMC-Heritage Valley Health System Beaver
- Lehigh Valley Hospital - MuhlenbergRecruiting
- Geisinger Medical Center
- Pocono Medical CenterRecruiting
- UPMC Cancer Centers - Arnold Palmer Pavilion
- Geisinger Medical Center-Cancer Center Hazleton
- Lehigh Valley Hospital-HazletonRecruiting
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- UPMC Cancer Center at UPMC McKeesport
- UPMC Hillman Cancer Center in Coraopolis
- UPMC-Magee Womens Hospital
- UPMC-Presbyterian Hospital
- UPMC-Saint Margaret
- University of Pittsburgh Cancer Institute (UPCI)Recruiting
- UPMC-Shadyside Hospital
- UPMC-Passavant Hospital
- UPMC-Saint Clair Hospital Cancer Center
- Geisinger Cancer Services-Pottsville
- Guthrie Medical Group PC-Robert Packer HospitalRecruiting
- Community Medical Center
- Geisinger Medical Oncology-Selinsgrove
- UPMC Cancer Center at UPMC Northwest
- Geisinger Medical Group
- UPMC Uniontown Hospital Radiation Oncology
- UPMC Washington Hospital Radiation Oncology
- Reading HospitalRecruiting
- Geisinger Wyoming Valley/Henry Cancer Center
- UPMC SusquehannaRecruiting
- Smilow Cancer Hospital Care Center - WesterlyRecruiting
- Saint Joseph's/Candler - Bluffton CampusRecruiting
- Saint Francis Hospital
- Saint Francis Cancer Center
- South Carolina Cancer Specialists PCRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Vanderbilt-Ingram Cancer Center Cool SpringsRecruiting
- Thompson Cancer Survival Center
- Thompson Cancer Survival Center - West
- Thompson Oncology Group-Maryville
- Vanderbilt Breast Center at One Hundred OaksRecruiting
- Vanderbilt University/Ingram Cancer CenterRecruiting
- Thompson Oncology Group-Oak Ridge
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- Farmington Health Center
- Huntsman Cancer Institute/University of Utah
- South Jordan Health Center
- University of Vermont Medical CenterRecruiting
- University of Vermont and State Agricultural CollegeRecruiting
- University of Virginia Cancer Center
- Hematology Oncology Associates of Fredericksburg IncRecruiting
- Centra Lynchburg Hematology-Oncology Clinic Inc
- Virginia Cancer InstituteRecruiting
- Virginia Commonwealth University/Massey Cancer CenterRecruiting
- Shenandoah Oncology PCRecruiting
- Overlake Medical Center
- Jefferson HealthcareRecruiting
- Valley Medical CenterRecruiting
- North Star Lodge Cancer Center at Yakima Valley Memorial HospitalRecruiting
- Edwards Comprehensive Cancer Center
- Langlade Hospital and Cancer CenterRecruiting
- Duluth Clinic AshlandRecruiting
- Northwest Wisconsin Cancer CenterRecruiting
- Aurora Cancer Care-Southern Lakes VLCCRecruiting
- Marshfield Clinic-Chippewa CenterRecruiting
- Aurora Saint Luke's South ShoreRecruiting
- Marshfield Clinic Cancer Center at Sacred Heart
- Aurora Health Center-Fond du LacRecruiting
- Aurora Health Care Germantown Health CenterRecruiting
- Aurora Cancer Care-GraftonRecruiting
- Bellin Memorial Hospital
- Aurora BayCare Medical CenterRecruiting
- UW Cancer Center Johnson CreekRecruiting
- Aurora Cancer Care-Kenosha SouthRecruiting
- Gundersen Lutheran Medical CenterRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Aurora Bay Area Medical Group-MarinetteRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Aspirus Medford HospitalRecruiting
- Aurora Cancer Care-MilwaukeeRecruiting
- Aurora Saint Luke's Medical CenterRecruiting
- Medical College of Wisconsin
- Aurora Sinai Medical CenterRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- ProHealth D N Greenwald Center
- Cancer Center of Western WisconsinRecruiting
- ProHealth Oconomowoc Memorial Hospital
- Vince Lombardi Cancer Clinic - OshkoshRecruiting
- Aurora Cancer Care-RacineRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Lakeview Medical Center-Marshfield Clinic
- Marshfield Medical Center-Rice LakeRecruiting
- Vince Lombardi Cancer Clinic-SheboyganRecruiting
- Ascension Saint Michael's HospitalRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- Aurora Medical Center in SummitRecruiting
- Vince Lombardi Cancer Clinic-Two RiversRecruiting
- Aurora Cancer Care-Waukesha
- ProHealth Waukesha Memorial Hospital
- UW Cancer Center at ProHealth Care
- Aspirus Regional Cancer CenterRecruiting
- Marshfield Clinic-Wausau CenterRecruiting
- Aurora Cancer Care-Milwaukee WestRecruiting
- Aurora West Allis Medical CenterRecruiting
- Marshfield Medical Center - WestonRecruiting
- Aspirus Cancer Care - Wisconsin RapidsRecruiting
- Marshfield Clinic - Wisconsin Rapids CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm A (nivolumab, ipilimumab, sargramostim)
Arm B (nivolumab, ipilimumab)
INDUCTION THERAPY: Patients receive nivolumab IV over 30 minutes on day 1 of each cycle, ipilimumab IV over 30 minutes on day 1 of each cycle, and sargramostim SC on days 1-14 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive nivolumab and sargramostim as in Induction therapy. Patients with PR, SC, or CR at 24 weeks may continue maintenance therapy for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI, CT scan, and blood sample collection throughout the study. Patients may also undergo a MUGA during screening, as well as an ECHO throughout the trial as clinically indicated.
INDUCTION THERAPY: Patients receive nivolumab and ipilimumab as in Arm I. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive nivolumab as in Induction therapy. Patients with PR, SD, or CR at 24 weeks may continue maintenance therapy for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI, CT scan, and blood sample collection throughout the study. Patients may also undergo a MUGA during screening, as well as an ECHO throughout the trial as clinically indicated.